Suppliers and packagers for MILRINONE LACTATE IN PLASTIC CONTAINER

MILRINONE LACTATE IN PLASTIC CONTAINER

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma Farmaceutica	MILRINONE LACTATE IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	090038	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9718-10	10 CONTAINER in 1 PACKAGE (0143-9718-10) / 200 mL in 1 CONTAINER (0143-9718-01)	2010-01-21
Hikma Farmaceutica	MILRINONE LACTATE IN PLASTIC CONTAINER	milrinone lactate	INJECTABLE;INJECTION	090038	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9719-10	10 CONTAINER in 1 PACKAGE (0143-9719-10) / 100 mL in 1 CONTAINER (0143-9719-01)	2010-01-21

Suppliers for MILRINONE LACTATE IN PLASTIC CONTAINER

Last updated: August 2, 2025

Overview of Milrinone Lactate

Milrinone lactate is a phosphodiesterase-3 inhibitor primarily used as an inotropic agent for managing acute heart failure and low cardiac output syndromes. Its clinical efficacy hinges on precise formulations, typically administered via IV infusion in plastic containers that ensure stability and bioavailability. The global demand for milrinone lactate in plastic containers has expanded alongside cardiology and critical care specialties, prompting a growing landscape of manufacturing and supply options.

Leading Manufacturers of Milrinone Lactate in Plastic Containers

1. Fresenius Kabi

Fresenius Kabi is a dominant player in the infusion solutions market, offering pharmaceutical-grade milrinone lactate in ready-to-use plastic containers. Their formulations are characterized by high purity standards, extensive validation processes, and compliance with international regulatory requirements. The company's widespread global manufacturing facilities enable reliable supply chains and consistent quality.

2. Pfizer Inc.

Pfizer has historically produced milrinone in various formulations, including plastic container presentations suitable for intravenous use. Their formulations are designed for stability and compatibility with hospital infusion systems, often packaged in prefilled or large-volume plastic bags to facilitate rapid administration in critical care settings.

3. Teva Pharmaceutical Industries

Teva offers generics of milrinone lactate, accessible in plastic containers as part of their cardiovascular portfolio. Their products adhere to stringent pharmacopeial standards, with an emphasis on affordability and supply security, especially in emerging markets.

4. Hikma Pharmaceuticals

Hikma manufactures a range of injectable medications, including milrinone lactate in plastic containers. Their formulations are designed to meet the needs of hospitals in the Middle East, Africa, and Europe, emphasizing safety, efficacy, and regulatory compliance.

5. Sun Pharmaceutical Industries

Sun Pharma supplies milrinone lactate in plastic containers as part of its extensive portfolio of sterile injectables. Their products undergo rigorous quality control, aligning with both US FDA and other international standards.

6. Lannett Company Inc.

Lannett produces off-patent injectable drugs, including milrinone lactate, available in plastic containers. Their supply chain emphasizes cost-effectiveness and broad market access.

Regional and Market-Specific Suppliers

• China & India: Several local pharmaceutical manufacturers supply milrinone lactate in plastic containers, often catering to domestic markets under local regulatory approvals. Companies such as Zhejiang Haichen Pharmaceutical and Lomus Pharmaceutical are notable for injectable formulations.

• Europe: Besides major multinational corporations, regional players like B. Braun and Novartis distribute milrinone in plastic containers, emphasizing high-quality standards aligned with EMA regulations.

• United States: The US market is predominantly served by companies like Pfizer, Teva, and Fresenius Kabi, with products approved by the FDA, in line with the strict US pharmacopeial standards.

Key Considerations When Selecting Suppliers

• Regulatory Compliance: Suppliers must meet EMA, FDA, or equivalent national standards, including cGMP compliance and active pharmacovigilance programs.

• Product Stability and Packaging: Plastic container suitability related to drug stability over shelf life, compatibility with infusion devices, and ease of use.

• Supply Chain Reliability: Consistent production capabilities, logistical robustness, and contingency planning are critical for patient safety.

• Pricing and Market Access: Competitive pricing, especially in long-term procurement or bulk purchasing strategies, influences supplier selection.

• Quality Assurance: Certification such as ISO 13485, batch-to-batch consistency, and rigorous testing protocols.

Emerging Trends in Supplier Networks

• Local Manufacturing: Growing emphasis on regional suppliers to reduce lead times and ensure compliance with local regulatory frameworks.

• Innovative Packaging Solutions: Development of pre filled, molded plastic systems to improve safety and ease of administration.

• Sustainability Focus: Suppliers investing in eco-friendly packaging and manufacturing processes to reduce environmental impact.

Conclusion

The landscape for suppliers of milrinone lactate in plastic containers features several established multinational firms supplemented by regional producers. Decision-makers should prioritize regulatory compliance, supply reliability, and product quality in their supplier evaluation processes. Emerging suppliers in developing markets present opportunities for cost-effective sourcing, but rigorous due diligence remains essential.

Key Takeaways

• Major suppliers include Fresenius Kabi, Pfizer, Teva, Hikma, and Sun Pharmaceutical, all renowned for quality and regulatory standards.
• Regional manufacturers are vital for local market demands, especially in Asia and Europe.
• Regulatory compliance and product stability are the primary considerations for procurement.
• Emerging packaging innovations aim to enhance safety, convenience, and environmental sustainability.
• A diversified supplier base minimizes risks associated with supply disruptions, ensuring continuous patient care.

FAQs

1. Which supplier offers the most widely used milrinone lactate in plastic containers globally?
Fresenius Kabi is often regarded as the leading supplier due to its extensive global presence, high-quality standards, and broad distribution network.

2. Are there generic alternatives available for milrinone lactate in plastic containers?
Yes, multiple generic manufacturers, such as Teva and Hikma, produce milrinone lactate in plastic containers, offering cost-effective options while maintaining regulatory compliance.

3. What are the regulatory considerations when sourcing milrinone lactate from international suppliers?
Sourcing must adhere to the respective region’s regulatory framework—FDA in the US, EMA in Europe, or local authorities in other countries—focusing on manufacturing standards, batch testing, and product stability data.

4. How does packaging impact the stability of milrinone lactate?
Plastic container compatibility and container material (like polyvinyl chloride or polypropylene) influence drug stability and compatibility, requiring suppliers to validate their packaging for the specific formulation.

5. Are there sustainable options among suppliers for milrinone lactate packaging?
Several suppliers are exploring environmentally friendly packaging solutions, such as biodegradable plastics and reduced plastic usage, aligning with global sustainability initiatives.

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Sources

1. [1] Fresenius Kabi Official Website.
2. [2] Pfizer Product Portfolio.
3. [3] Teva Pharmaceutical Official Catalog.
4. [4] Hikma Pharmaceuticals Product Guide.
5. [5] Sun Pharmaceutical Industries Ltd. Product Details.